Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient

NCT ID: NCT01952210

Last Updated: 2014-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

Brief Summary

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In this randomized pilot study, a nutritional consultation combining exercise program is planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation. The purpose of this study is to determine the effects of nutritional and exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation.

Detailed Description

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Patients with esophageal cancer are often malnourished at presentation due to the primary symptom of dysphagia. Treatments for esophageal cancer are commonly multimodal, incorporating polychemotherapy, radiotherapy and surgery. These treatments frequently cause or exacerbate poor nutritional status. Recent literature has proved that malnutrition is associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, worse quality of life and lower survival rate. The aim of this study was to investigate the effectiveness of an intensive nutritional consultation and exercise program on nutritional status and outcomes in patients undergoing chemoradiation for esophageal cancer.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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nutrition consultation and exercise program

individual nutritional consultation and exercise

Group Type EXPERIMENTAL

nutritional consultation and exercise program

Intervention Type BEHAVIORAL

The protocol involved 20-30 minutes of individual-based nutrition consultation every week during the 8-week chemoradiation therapy. The exercise program consisted of upper extremity muscle training and walking exercise at 45%-65% of maximal heart rate reserve, 3 times per week, 20-30 minutes per session.

usual care

pre-CCRT education included self-care during CCRT and body weight maintenance

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type BEHAVIORAL

pre-CCRT education included self-care during CCRT and body weight maintenance

Interventions

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nutritional consultation and exercise program

The protocol involved 20-30 minutes of individual-based nutrition consultation every week during the 8-week chemoradiation therapy. The exercise program consisted of upper extremity muscle training and walking exercise at 45%-65% of maximal heart rate reserve, 3 times per week, 20-30 minutes per session.

Intervention Type BEHAVIORAL

usual care

pre-CCRT education included self-care during CCRT and body weight maintenance

Intervention Type BEHAVIORAL

Other Intervention Names

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nutritional consultation pre-CCRT education

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated
* Informed consent signed

Exclusion Criteria

* stage IV, underwent palliative chemotherapy or radiotherapy patient
* clinically significant cardiac or pulmonary disease
* Unable to walk or exercise
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheryl Chia-Hui Chen

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201205017RIC

Identifier Type: -

Identifier Source: org_study_id

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